Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS)

• Status: Completed
• Trial end date: 2018-06-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this crossover trial is to investigate whether atomoxetine (versus placebo) improves memory function in persons with memory deficits due to multiple sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Diagnosis of Multiple Sclerosis based on the Revised McDonald criteria

• Age 21 - 60 years.

• Patient self-report of memory decline from previously higher level of functioning.

• Memory Impairment on validated neuropsychological memory screening tests, as follows:

1. performance ≤16th percentile on both (i) Rey Auditory Verbal Learning Test (RAVLT) Total Learning (TL) and (ii) WMS-IV Visual Reproduction I (VR-I); and b) mean normative memory performance (RAVLT TL and WMS-IV VR-I) is at least 1.0 standard deviation below expectations based on the Wechsler Test of Adult Reading (WTAR)

Exclusion Criteria:

• Current stimulant medication usage.

• Previous diagnosis or treatment for ADHD or any neurologic condition other than multiple sclerosis (e.g., traumatic brain injury, epilepsy)

• Clinical relapse of MS within 60 days of screening,

• Change in disease-modifying therapy within 90 days of screening,

• Below average estimated premorbid intelligence (WTAR, < 16th percentile),

• Severe cognitive impairment indicated by a Mini-Mental Status Examination (MMSE) < 24/30.

• Contraindications for atomoxetine use: (a) self-reported history of suicidal ideation within the last twelve months (Columbia Suicide Severity Rating Scale), (b) diagnosis of bipolar illness, (c) moderate or severe current depressive symptomatology (Beck Depression Inventory Fast Screen ≥ 9), (d) diagnosis of hepatic disease, (e) narrow angle glaucoma, (f) pheochromocytoma, (g) monoamine oxidase inhibitor within 14 days of study drug start, (h) taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine), (i) diagnosis of heart disease, (j) pregnant or planning pregnancy during the study period, (k) breastfeeding, (l) hypersensitivity to atomoxetine or component of formulation.